Food Regulation. Neal D. Fortin

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СКАЧАТЬ style="font-size:15px;">      Under Central Hudson, we are obliged to evaluate a government scheme to regulate potentially misleading commercial speech by applying a three‐part test. First, we ask whether the asserted government interest is substantial. The FDA advanced two general concerns: protection of public health and prevention of consumer fraud. The Supreme Court has said “there is no question that [the government’s] interest in ensuring the accuracy of commercial information in the marketplace is substantial,” and that government has a substantial interest in “promoting the health, safety, and welfare of its citizens.” At this level of generality, therefore, a substantial governmental interest is undeniable.

      The more significant questions under Central Hudson are the next two factors: “whether the regulation directly advances the governmental interest asserted,” and whether the fit between the government’s ends and the means chosen to accomplish those ends “is not necessarily perfect, but reasonable,” We think that the government’s regulatory approach encounters difficulty with both factors.

      It is important to recognize that the government does not assert that appellants’ dietary supplements in any fashion threaten consumer’s health and safety. The government simply asserts its “common sense judgment” that the health of consumers is advanced directly by barring any health claims not approved by the FDA. Because it is not claimed that the product is harmful, the government’s underlying—if unarticulated—premise must be that consumers have a limited amount of either attention or dollars that could be devoted to pursuing health through nutrition, and therefore products that are not indisputably health enhancing should be discouraged as threatening to crowd out more worthy expenditures. We are rather dubious that this simplistic view of human nature or market behavior is sound, but, in any event, it surely cannot be said that this notion—which the government does not even dare openly to set forth—is a direct pursuit of consumer health; it would seem a rather indirect route, to say the least.

      On the other hand, the government would appear to advance directly its interest in protecting against consumer fraud through its regulatory scheme. If it can be assumed—and we think it can—that some health claims on dietary supplements will mislead consumers, it cannot be denied that requiring FDA pre‐approval and setting the standard extremely, perhaps even impossibly, high will surely prevent any confusion among consumers. We also recognize that the government’s interest in preventing consumer fraud/confusion may well take on added importance in the context of a product, such as dietary supplements, that can affect the public’s health.

      The difficulty with the government’s consumer fraud justification comes at the final Central Hudson factor: Is there a “reasonable” fit between the government’s goals and the means chosen to advance those goals? The government insists that it is never obliged to utilize the disclaimer approach, because the commercial speech doctrine does not embody a preference for disclosure over outright suppression. Our understanding of the doctrine is otherwise….

      Our rejection of the government’s position that there is no general First Amendment preference for disclosure over suppression, of course, does not determine that any supposed weaknesses in the claims at issue can be remedied by disclaimers and thus does not answer whether the subregulations, 21 C.F.R. § 101.71(a), (c), (e); id. § 101‐79(c)(2)(i)(G), are valid. The FDA deemed the first three claims—(1) “Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers,” (2) “Consumption of fiber may reduce the risk of colorectal cancer,” and (3) “Consumption of omega‐3 fatty acids may reduce the risk of coronary heart disease”—to lack significant scientific agreement because existing research had examined only the relationship between consumption of foods containing these components and the risk of these diseases. The FDA logically determined that the specific effect of the component of the food constituting the dietary supplement could not be determined with certainty… . But certainly this concern could be accommodated, in the first claim for example, by adding a prominent disclaimer to the label along the following lines: “The evidence is inconclusive because existing studies have been performed with foods containing antioxidant vitamins, and the effect of those foods on reducing the risk of cancer may result from other components in those foods.” A similar disclaimer would be equally effective for the latter two claims.

      The FDA’s concern regarding the fourth claim—“0.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form”—is different from its reservations regarding the first three claims; the agency simply concluded that “the scientific literature does not support the superiority of any one source [of folic acid] over others.” But it appears that credible evidence did support this claim (concluding that “losses [of folic acid] in cooking and canning [foods] can be very high due to heat destruction”), and we suspect that a clarifying disclaimer could be added to the effect that “The evidence in support of this claim is inconclusive.”

The government’s general concern that, given the extensiveness of government regulation of the sale of drugs, consumers might assume that a claim on a supplement’s label is approved by the government, suggests an obvious answer: The agency could require the label to state that “The FDA does not approve this claim.” Similarly, the government’s interest in preventing the use of labels that are true but do not mention adverse effects would seem to be satisfied—at least ordinarily—by inclusion of a prominent disclaimer setting forth those adverse effects.

      The government disputes that consumers would be able to comprehend appellants’ proposed health claims in conjunction with the disclaimers we have suggested—this mix of information would, in the government’s view, create confusion among consumers. But all the government offers in support is the FDA’s pronouncement that “consumers would be considerably confused by a multitude of claims with differing degrees of reliability.” Although the government may have more leeway in choosing suppression over disclosure as a response to the problem of consumer confusion where the product affects health, it must still meet its burden of justifying a restriction on speech—here the FDA’s conclusory assertion falls far short.

We do not presume to draft precise disclaimers for each of appellants’ four claims; we leave that task to the agency in the first instance. Nor do we rule out the possibility that where evidence in support of a claim is outweighed by evidence against the claim, the FDA could deem it incurable by a disclaimer and ban it outright.³⁹ For example, if the weight of the evidence were against the hypothetical claim that “Consumption of Vitamin E reduces the risk of Alzheimer’s disease,” the agency might reasonably determine that adding a disclaimer such as “The FDA has determined that no evidence supports this claim” would not suffice to mitigate the claim’s misleadingness. Finally, while we are skeptical that the government could demonstrate with empirical evidence that disclaimers similar to the ones we suggested above would bewilder consumers and fail to correct for deceptiveness, we do not rule out that possibility.

       B. The Unarticulated Standard

      Wholly apart from the question whether the FDA is obliged to consider appropriate disclaimers is appellants’ claim that the agency is obliged to give some content to the phrase “significant scientific agreement.” …

      Consideration of this constitutional claim seems unnecessary because we agree with appellants that the APA requires the agency to explain why it rejects their proposed health claims—to do so adequately necessarily implies giving some definitional content to the phrase “significant scientific agreement.” We think this proposition is squarely rooted in the prohibition under the APA that an agency not engage in arbitrary and capricious action. It simply will not do for a government agency to declare—without explanation—that a proposed course of private action is not approved. (“The agency must … articulate a satisfactory explanation for its action… .”). To refuse to define the criteria it is applying is equivalent to simply СКАЧАТЬ